Sildenafil Citrate

Product NDC: 50436-0036
11-digit product format: 504360036
Labeler code: 50436
Product ID: 50436-0036_8a240812-6508-4efa-8335-eb1be7af89e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sildenafil citrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Services
Application: NDA020895
Marketing category: NDA
Marketing start: 2017-12-01
Marketing end: 0000-00-00
Substance: SILDENAFIL CITRATE
Active strength: 100 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50436-0036		I	Inactivated by FDA		2026-08-17
excluded package	package	50436-0036	50436-0036-1	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0036-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0036-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0036-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0036-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0036-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0036-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-0036-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-0036-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-0036-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-0036-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-0036-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-0036-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-0036-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-0036-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-0036-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50436-0036-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50436-0036-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50436-0036-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50436-0036-1	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020895-001	VIAGRA	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27
N020895-002	VIAGRA	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27
N020895-003	VIAGRA	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020895-001	AB
N020895-002	AB
N020895-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020895-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020895-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020895-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020895-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020895-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020895-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020895-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020895-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020895-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020895-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020895-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020895-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020895-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020895-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020895-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020895-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020895-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020895-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020895-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020895-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020895-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020895-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020895-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020895-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020895-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020895-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020895-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020895-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020895-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020895-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020895-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020895-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020895-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020895-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020895-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020895-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020895-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020895-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020895-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020895-001	AB	1	`1e350fbaab3a…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020895-001	6469012	2019-10-22	U-155		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020895-001	6469012*PED	2020-04-22		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020895-002	6469012	2019-10-22	U-155		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020895-002	6469012*PED	2020-04-22		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020895-003	6469012	2019-10-22	U-155		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020895-003	6469012*PED	2020-04-22		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N020895-001	6469012*PED	2020-04-22		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020895-002	6469012*PED	2020-04-22		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020895-003	6469012*PED	2020-04-22		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020895-001	6469012*PED	2020-04-22		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020895-002	6469012*PED	2020-04-22		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020895-003	6469012*PED	2020-04-22		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020895-001	6469012	2019-10-22	U-155		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020895-001	6469012*PED	2020-04-22		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020895-002	6469012	2019-10-22	U-155		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020895-002	6469012*PED	2020-04-22		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020895-003	6469012	2019-10-22	U-155		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020895-003	6469012*PED	2020-04-22		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020895-001	6469012	2019-10-22	U-155		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020895-001	6469012*PED	2020-04-22		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020895-002	6469012	2019-10-22	U-155		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020895-002	6469012*PED	2020-04-22		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020895-003	6469012	2019-10-22	U-155		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020895-003	6469012*PED	2020-04-22		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020895-001	6469012	2019-10-22	U-155		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020895-001	6469012*PED	2020-04-22		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020895-002	6469012	2019-10-22	U-155		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020895-002	6469012*PED	2020-04-22		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020895-003	6469012	2019-10-22	U-155		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020895-003	6469012*PED	2020-04-22		Pediatric extension	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fabccea2-36c8-9268-ee44-ec231455538f	Product name	9	20241217
ac996ae9-22a2-41c2-bb86-913c4aef95ad	Product name	1	20230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fc	Product name	9	20220613

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-0036-1	2021-01-29	C162847	48780-1	ba0f9c33-52d9-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use SILDENAFIL CITRATE TABLETS safely and effectively. See full prescribing information for SILDENAFIL CITRATE TABLETS. SILDENAFIL CITRATE TABLETS (sildenafil citrate) tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-0036-1	Sildenafil Citrate	1080 in 1 CASE	TABLET, FILM COATED	1080		4
50436-0036-1	Sildenafil Citrate	1 in 1 POUCH	TABLET, FILM COATED	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0036	SILDENAFIL CITRATE TABLET, FILM COATED [UNIT DOSE SERVICES]	4	Legacy NDC, 2 package rows	20191120_7c3798c1-7884-4943-a59e-079524e12512.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil Citrate	SILDENAFIL CITRATE	Mylan Pharmaceuticals Inc.	98a9897b-0cbc-4ea6-9ac2-4dd719a2ede0	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020895 application number: NDA020895
Viagra	SILDENAFIL CITRATE	Viatris Specialty LLC	d905dc8d-917f-4ea3-a4ee-a1ecf6967d4e	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020895 application number: NDA020895
Viagra	SILDENAFIL CITRATE	PFIZER LABORATORIES DIV PFIZER INC	0b0be196-0c62-461c-94f4-9a35339b4501	2017-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020895 application number: NDA020895

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BW9B0ZE037	SILDENAFIL CITRATE	171599-83-0	SILDENAFIL CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314229	sildenafil citrate 100 MG Oral Tablet	PSN	7c3798c1-7884-4943-a59e-079524e12512	4
312950	sildenafil citrate 50 MG Oral Tablet	PSN	7c3798c1-7884-4943-a59e-079524e12512	4
314229	sildenafil 100 MG Oral Tablet	SCD	7c3798c1-7884-4943-a59e-079524e12512	4
312950	sildenafil 50 MG Oral Tablet	SCD	7c3798c1-7884-4943-a59e-079524e12512	4
314229	sildenafil 100 MG (as sildenafil citrate) Oral Tablet	SY	7c3798c1-7884-4943-a59e-079524e12512	4
312950	sildenafil 50 MG (as sildenafil citrate) Oral Tablet	SY	7c3798c1-7884-4943-a59e-079524e12512	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-0036-1	50436003601	1080 in 1 CASE	Historical